About

Kuker Regulatory Consulting, LLC. is a biopharmaceutical consulting firm that assists clients in the navigation of regulatory issues and government submissions, particularly in the following areas:

• US drug development and registration
• FDA meetings, preIND, IND, NDA, DMF, BLA
• Orphan product designation
• Regulatory strategy
• Dossier preparation and project management
• Regulatory compliance from early-stage development to post-marketed products
• Post-marketing advertising and promotion

Marie Kuker brings over 30 years of regulatory affairs experience to the firm. She is a pharmacist, Regulatory Affairs Certified, and a Fellow of the Regulatory Affairs Professional Society.